Baxter Healthcare Corporation: Medical Device Recall in 2024 - (Recall #: Z-0665-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CMUS, d) PC0608NBIO: 6X8CMUS, e) PC0814NBIO: 8X14CMUS

Product Classification:

Class II

Date Initiated: December 6, 2023

Date Posted: January 17, 2024

Recall Number: Z-0665-2024

Event ID: 93503

Reason for Recall:

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

Status: Ongoing

Product Quantity:

Code Information:

a) PC1016NBIO: UDI/DI 85412530604, b) PC1225NBIO: UDI/DI 85412530628, c) PC0404NBIO: UDI/DI 85412530529, d) PC0608NBIO: UDI/DI 85412530567, e) PC0814NBIO: UDI/DI 85412530581 All serial numbers

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated